Statistical Considerations Support the Supreme Court’s Decision in Matrixx Initiatives V. Siracusano

16 Pages Posted: 11 Sep 2011

See all articles by Joseph L. Gastwirth

Joseph L. Gastwirth

George Washington University - Columbian College of Arts and Sciences

Date Written: September 10, 2011

Abstract

In Matrixx Initiatives v. Siracusano, 568 U.S. (2011), the Supreme Court ruled that information about the number of adverse events occurring to users of a drug need not be sufficiently numerous to reach statistically significance before this knowledge should be disclosed to potential investors. None of the opinions or briefs presented a statistical analysis of the data. This paper provides a statistical method for comparing the proportion of individuals with a particular adverse event who had used the product under investigation with the market share of the product and concludes that there was a statistically significant excess of cases of loss of smell in users of Zicam nasal spray made by Matrixx. Because adverse event reports are not based on a random sample, this conclusion is subjected to a sensitivity analysis showing that even if Zicam users were twice as likely to take the medicine as users of other cold medicines and twice as likely to report a problem statistical significance remains. It is demonstrated that the studies of effectiveness of Zicam were too small to detect a small but important risk to users. Finally, public policy concerns also support the Court’s decision since a drug manufacturer who receives complaints but does not disclose them effectively eliminates the possibility that other medical researchers would carry out an epidemiologic study.

Suggested Citation

Gastwirth, Joseph L., Statistical Considerations Support the Supreme Court’s Decision in Matrixx Initiatives V. Siracusano (September 10, 2011). Available at SSRN: https://ssrn.com/abstract=1925465 or http://dx.doi.org/10.2139/ssrn.1925465

Joseph L. Gastwirth (Contact Author)

George Washington University - Columbian College of Arts and Sciences ( email )

Washington, DC 20052
United States
202-994-6458 (Phone)
202-994-6917 (Fax)

HOME PAGE: http://www.gwu.edu/~stat/gastwirth.html

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